July 26, 2011

Elsevier announced the publication of several commentaries in the scientific journal Reproductive BioMedicine Online on the subject of how many embryos it is safe and proper to place in a uterus, and how best to regulate this decision. It is a dilemma faced by all patients anxiously caught between no pregnancies at all or facing the prospect of twins or triplets. In this difficult place it is often all too easy to think that the latter option must be the best. But is it?

The debate was sparked by a paper from Dr Francois Bissonnette et al., which describes the impact of the implementation of new legislation in Quebec, Canada, on the rates of multiple births and pregnancy. This legislation was introduced in August 2010 in conjunction with state-finance for assisted reproduction treatments. The aim was to reduce multiple pregnancies, described as "the major negative side effect of ART (Assisted Reproductive Technology), by controlling the number of embryos that could be transferred in any one cycle.

In the first three months of this programme, 1353 cycles of IVF were performed in the five Quebec-based ART centers. Single embryo transfers accounted for 50% of transfers compared with only 1.6% prior to legislation  a big decline. The effect of this was to reduce the overall clinical pregnancy rate from 42% to 32% per transfer  for the first time describing a diminishment of overall pregnancy results. Such an outcome is not unexpected, since embryologists cannot always predict the health of the embryos being transferred. In contrast, previous work from Scandinavia and Belgium has claimed that pregnancy rate is not affected (or only marginally so) when embryo numbers are reduced  perhaps an unrealistic routine outcome? However, the multiple pregnancy rate was reduced from 25.6% to only 3.7%. It is suggested that having state-financed ART created an environment in which the more aggressive use of single embryo transfer became possible, patients being prepared to risk a failure first time round, because the subsequent use of frozen embryos and/or a second cycle of treatment was still affordable. The authors say: "It is logical to use the cumulative pregnancy rate or cumulative live birth rate per initiated cycle, combining results from transfer of fresh and frozen embryos, as the standard measure of a patient's chances for a baby."

However, this paper then provoked a responding commentary by Dr Norbert Gleicher of Yale and New York, who attacks both the rationale and the ethics of the Quebec approach. First, he agrees that triplet pregnancies are a high risk to both mother and off-spring. But then he goes on to claim that both the risk to mother and babies, as well as the overall costs to the health system, of two serial singleton pregnancies are as great as, if not greater than, those of a twin pregnancy, implying that the gains of single embryo transfer are at best illusionary. Second, Gleicher objects to the intrusion of government into health care decisions on the grounds that this interferes with a patient's right to self-determination or "to choose". Indeed, Gleicher vociferously advocates the USA free market model over the European-style sympathy for government intervention in health care, his hope being "to keep government out of medicine".

This blast of free-market proselytizing is countered, appropriately from Europe, in a detailed response from Dr Yakoub Khalaf et al. of Guy's and Thomas' Hospital, London, who claim that practice should be based on solid data rather than personal judgment  and proceed to dissect and question Gleicher's calculations on the relative outcomes of double versus serial single embryo transfer. They set the right of patient self-determination against a doctor's ethical duty to practice in the best interests of her patients, and not to acquiesce passively to requests she knows to be risky, stressing that the risks from twin pregnancies are real and borne by women and children, not their doctors. They end by suggesting that Government legislation, responsibly applied, as described by Bissonnette et al., can and should be an aid to clinical leadership in decision-making with patients, and is demonstrably in the interests of the health of the patients and their children-to-be. "Yes we can" they claim  implicitly aligning themselves with Obama in his political tussle with Congress over health care policy.

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